tangent4ronpaul
Banned
- Joined
- May 11, 2007
- Messages
- 21,101
http://seekingalpha.com/article/856...t-biotherapeutics-and-novartis-have-in-common
On August 2, 2012, Representative Ron Paul of Texas stood up in front of Congress and introduced the Compassionate Freedom of Choice Act. The bill, if passed, would legalize experimental drug use by terminally ill patients if they so chose, without interference from the FDA. At the link above, you will find Dr. Paul's speech, where he recounts story after story of terminally ill cancer patients who were denied access to potentially life-saving drugs because, alas, they were not yet FDA approved. Those patients died.
The bill has virtually no chance of passing. The reason is simple. If the FDA is not allowed complete control over the pharmaceutical industry, then any cracks in its authority may wake people up to the possibility that they actually cause harm. Imagine if these experimental drugs actually helped some patients and saved their lives without FDA approval or in the legal avenue of an FDA approved clinical trial. People would start questioning the FDA. The FDA would have to go on the defensive. Some people up on top may lose their jobs, and that is unacceptable. This is why no government agency, once enacted, ever dies.
The FDA's effects on the health care industry and its investment community are also injurious.
...
He's right of course, but the fact that asymmetric investment opportunities exist in biotech specifically is not good for the industry, much like booms and busts in any industry are bad for said industry (think housing and dot coms), or a large income gap and no middle class is bad for a country. The main reason these asymmetric opportunities exist is not that people don't know about NWBO or DNDN or what have you, but that these companies have to invest all their capital into a government mandated process of clinical trials that costs huge amounts of money, are regulated more than a guy on a strict 100% Fiber One cereal diet, are decided by men appointed by bureaucrats, and present needless do-or-die scenarios to the companies in question, especially development stage ones. If do - you're rich. If die - you lose everything.
...
Two years of buttering up bureaucrats so dying patients can have the right to try an experimental medication that could possibly save their lives? The thought of arresting a dying cancer patient for trying an experimental drug without MHRA or FDA approval is…well, I'll leave the word up to you. And how much money did this cost NW Bio? It's amazing that NW Bio has made it this far considering its size, but what if these regulations had killed them? What would have happened to their research? And yes, if they break through the Phase III barrier, this could be one of those "asymmetric investment opportunities".
But the FDA has other fans. It is NW Bio's large cap competitors that benefit most from bureaucratic barriers to entry.
...
But to get through the bureaucratic barriers, she needed to team up with Novartis who has experience in this sort of thing. So the pharma giant will own the drug in exchange for greasing the wheels of government.
Imagine if the Compassionate Freedom of Choice Act was law and just for the exception of terminally ill patients, the FDA stopped bothering drug makers. How much would it cost Dr. June to try out her therapy on dying leukemia patients? Would she need $20 million from Novartis? Would the FDA be able to stop the public clamor to get it to market immediately, clinical trials be damned, if and when, patient after patient, their disease was eradicated? Would she have any trouble getting venture capitalists to invest rather than giving it to Novartis in exchange for help getting through government obstacles?
Novartis wouldn't be too happy I suppose, because then they wouldn't be able to profit from the drug's success. Neither would the FDA, who would inexorably lose their grasp on the whole industry to private drug safety inspection companies who would quickly fill the void and compete with one another. Perhaps I'm dreaming.
For now, I suppose, we can only place our bets on companies that have the best shot at pleasing the bureaucrats, and leave terminally ill patients high and dry. NW Bio and Novartis look promising. Hopefully they will both save thousands of lives in the near future. If only the FDA will let them.
ABOLISH THE FDA!!!!
-t
On August 2, 2012, Representative Ron Paul of Texas stood up in front of Congress and introduced the Compassionate Freedom of Choice Act. The bill, if passed, would legalize experimental drug use by terminally ill patients if they so chose, without interference from the FDA. At the link above, you will find Dr. Paul's speech, where he recounts story after story of terminally ill cancer patients who were denied access to potentially life-saving drugs because, alas, they were not yet FDA approved. Those patients died.
The bill has virtually no chance of passing. The reason is simple. If the FDA is not allowed complete control over the pharmaceutical industry, then any cracks in its authority may wake people up to the possibility that they actually cause harm. Imagine if these experimental drugs actually helped some patients and saved their lives without FDA approval or in the legal avenue of an FDA approved clinical trial. People would start questioning the FDA. The FDA would have to go on the defensive. Some people up on top may lose their jobs, and that is unacceptable. This is why no government agency, once enacted, ever dies.
The FDA's effects on the health care industry and its investment community are also injurious.
...
He's right of course, but the fact that asymmetric investment opportunities exist in biotech specifically is not good for the industry, much like booms and busts in any industry are bad for said industry (think housing and dot coms), or a large income gap and no middle class is bad for a country. The main reason these asymmetric opportunities exist is not that people don't know about NWBO or DNDN or what have you, but that these companies have to invest all their capital into a government mandated process of clinical trials that costs huge amounts of money, are regulated more than a guy on a strict 100% Fiber One cereal diet, are decided by men appointed by bureaucrats, and present needless do-or-die scenarios to the companies in question, especially development stage ones. If do - you're rich. If die - you lose everything.
...
Two years of buttering up bureaucrats so dying patients can have the right to try an experimental medication that could possibly save their lives? The thought of arresting a dying cancer patient for trying an experimental drug without MHRA or FDA approval is…well, I'll leave the word up to you. And how much money did this cost NW Bio? It's amazing that NW Bio has made it this far considering its size, but what if these regulations had killed them? What would have happened to their research? And yes, if they break through the Phase III barrier, this could be one of those "asymmetric investment opportunities".
But the FDA has other fans. It is NW Bio's large cap competitors that benefit most from bureaucratic barriers to entry.
...
But to get through the bureaucratic barriers, she needed to team up with Novartis who has experience in this sort of thing. So the pharma giant will own the drug in exchange for greasing the wheels of government.
Imagine if the Compassionate Freedom of Choice Act was law and just for the exception of terminally ill patients, the FDA stopped bothering drug makers. How much would it cost Dr. June to try out her therapy on dying leukemia patients? Would she need $20 million from Novartis? Would the FDA be able to stop the public clamor to get it to market immediately, clinical trials be damned, if and when, patient after patient, their disease was eradicated? Would she have any trouble getting venture capitalists to invest rather than giving it to Novartis in exchange for help getting through government obstacles?
Novartis wouldn't be too happy I suppose, because then they wouldn't be able to profit from the drug's success. Neither would the FDA, who would inexorably lose their grasp on the whole industry to private drug safety inspection companies who would quickly fill the void and compete with one another. Perhaps I'm dreaming.
For now, I suppose, we can only place our bets on companies that have the best shot at pleasing the bureaucrats, and leave terminally ill patients high and dry. NW Bio and Novartis look promising. Hopefully they will both save thousands of lives in the near future. If only the FDA will let them.
ABOLISH THE FDA!!!!
-t
